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NCR Acquires Foremost Business Systems, Brings Restaurant Technology and Support to Minneapolis

NCR Acquires Foremost Business Systems, Brings Restaurant Technology and Support to Minneapolis

ATLANTA–(BUSINESS WIRE)–
NCR Corporation (NYSE: NCR), a leading enterprise technology provider, today announced the acquisition of Foremost Business Systems, a point-of-sale (POS) and restaurant solutions provider in Minneapolis.

This transaction further expands the reach of NCR’s restaurant technology – which is trusted by more than 100,000 restaurants around the world. Solutions including the signature NCR Aloha POS platform and NCR Aloha Essentials subscription package provide everything restaurants need to run their business, boost efficiency and increase growth.

“Bringing Foremost Business Systems into the NCR family aligns with our strategy to increase our capabilities to deliver our solutions and serve our customers in thriving local restaurant markets, like Minneapolis,” said NCR CEO Michael D. Hayford.

NCR will maintain Foremost Business Systems’ existing customer sites with the Foremost Business Systems management team and staff of local Minneapolis restaurant experts. The integration of the Foremost Business Systems team into the NCR local office network accelerates NCR’s ability to bring innovative solutions to Minnesota and Western Wisconsin.

“Our customers will continue to work with the same team they’ve grown familiar with through the years – and now, we have access to global resources and can deliver even better service,” said Lori Alwin, president of Foremost Business Systems.

NCR’s direct presence in the communities we serve and authorized resellers provide local sales and service to small- and medium-sized restaurant businesses across North America. Learn more about our solutions here.

About NCR Corporation

NCR Corporation (NYSE: NCR) is a leading software- and services-led enterprise provider in the financial, retail and hospitality industries. NCR is headquartered in Atlanta, Ga., with 36,000 employees globally. NCR is a trademark of NCR Corporation in the United States and other countries.

Web site: www.ncr.com

Twitter: @NCRCorporation

Facebook: www.facebook.com/ncrcorp

LinkedIn: www.linkedin.com/company/ncr-corporation

YouTube: www.youtube.com/user/ncrcorporation

NCR Investor Contact

Michael Nelson

NCR Corporation

678-808-6995

[email protected]

NCR Media Contact

Scott Sykes

NCR Corporation

212-589-8428

[email protected]

KEYWORDS: United States North America Georgia

INDUSTRY KEYWORDS: Software Technology Retail Restaurant/Bar

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Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke® Kit for the Treatment of Severe Hypoglycemia

Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke® Kit for the Treatment of Severe Hypoglycemia

First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue

Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences

Gvoke Kit eliminates the need for reconstitution

Gvoke Kit availability anticipated in early Q1 2022

CHICAGO–(BUSINESS WIRE)–
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke Kit availability early in the first quarter of 2022.

“Offering three different administration options – Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event. These innovative formats provide the reliability of a ready-to-use liquid glucagon while offering multiple administration options for patients and caregivers,” said Paul R. Edick, Chairman and CEO of Xeris. “In particular for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe, Gvoke Kit reduces the number of steps by eliminating reconstitution – the most common mistake in correctly administering the conventional glucagon kit.”

The sNDA approval was supported by a pharmacokinetic study demonstrating bioequivalence of a 1 mg Gvoke dose administered via a vial and syringe kit (Gvoke Kit) to that of 1 mg Gvoke administered as a pre-filled syringe (Gvoke PFS).

ABOUT Gvoke® (US) /Ogluo® (EU)

Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in September 2019 for use in the United States. Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above. Ogluo received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2020 and the European Commission (EC) granted the marketing authorisation on 11 February 2021. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo® (glucagon) injection on April 29, 2021. Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. In August 2021, the FDA approved Gvoke Kit, the first ready-to-use glucagon available in a single-use vial and single-use syringe kit for rescue.

INDICATION AND IMPORTANT SAFETY INFORMATION

GVOKE is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.

IMPORTANT SAFETY INFORMATION

Contraindications

GVOKE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of the risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Warnings and Precautions

GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GVOKE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. GVOKE is contraindicated in patients with a prior hypersensitivity reaction.

GVOKE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for GVOKE administration to be effective. Patients with these conditions should be treated with glucose.

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

Adverse Reactions

Most common (≥5%) adverse reactions associated with GVOKE are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE. In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin.

Please see full Prescribing Information for GVOKE on www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc. by Pyramid Laboratories Inc., Costa Mesa, CA 92626.

About Xeris Pharmaceuticals, Inc.

Xeris (Nasdaq: XERS) is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the availability of Gvoke® Kit in the U.S. in the first quarter of 2022, the market and therapeutic potential of Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, the timing or likelihood of regulatory approval and commercialization of Gvoke® Kit and other statements containing the words “will,” “would,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the impact of COVID-19 on its business operations, its reliance on third-party suppliers for Gvoke® and Ogluo®, the regulatory approval of Gvoke® Kit, its ability to market and sell its products, if approved, and other factors discussed in the “Risk Factors” section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

[email protected]

312-736-1237

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Health FDA Diabetes Other Health General Health Pharmaceutical Biotechnology

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Legend Biotech Reports Second Quarter 2021 Financial Results and Recent Highlights

Legend Biotech Reports Second Quarter 2021 Financial Results and Recent Highlights

  • Investigational BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) granted priority review by the U.S. Food and Drug Administration for the treatment of relapsed or refractory multiple myeloma (RRMM)
  • A Marketing Authorisation Application (MAA) was accepted by the European Medicines Agency (EMA) for cilta-cel for the treatment of RRMM
  • New and updated cilta-cel data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Virtual Congress
  • New investment announced for facility in Belgium, expanding global presence for cell therapy manufacturing

SOMERSET, N.J.–(BUSINESS WIRE)–
Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported its 2021 second quarter unaudited financial results.

“We have made exciting progress in advancing our first investigational CAR-T therapy cilta-cel in the past few months, with key regulatory, data and manufacturing updates. This includes the acceptance of our applications for cilta-cel by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the presentation of additional efficacy and safety data from the CARTITUDE cilta-cel clinical development program at ASCO and EHA Annual meetings,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “We look forward to a momentous second half of the year as we work towards bringing cilta-cel to patients living with multiple myeloma and providing their healthcare providers a new therapeutic option, in collaboration with Janssen.”

Second Quarter 2021 Highlights

  • In May 2021, the rolling submission of the Biologics License Application (BLA) was accepted by the U.S. FDA for cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), following the submission by Legend Biotech’s collaborator, Janssen Biotech, Inc. (Janssen). As part of the BLA acceptance, the FDA granted cilta-cel priority review and set the Prescription Drug User Fee Act (PDUFA) target action date for November 29, 2021.
  • In May 2021, the Marketing Authorisation Application (MAA) submitted by Janssen was accepted by the European Medicines Agency (EMA) for cilta-cel for the treatment of adults with RRMM.
  • In addition, a submission for cilta-cel was made to the Brazilian Health Regulatory Agency by Janssen in April 2021.
  • Longer term data from the CARTITUDE-1 trial of cilta-cel in 97 heavily pretreated patients with RRMM, which was presented at the 2021 ASCO and EHA Annual meetings, showed 98 percent overall response rate, 80 percent stringent complete response rate (sCR), progression free survival rate of 66 percent and an overall survival (OS) rate of 81 percent at the 18-month follow-up. A full manuscript containing earlier data from the CARTITUDE-1 trial at 12.4-months of follow up was published in The Lancet in June 2021.
  • First results from Cohort A of the CARTITUDE-2 study of cilta-cel, which was featured at the 2021 ASCO and EHA Annual meetings, showed early and deep responses in the cohort of 20 patients with progressive MM after 1-3 prior lines of therapy, and who were lenalidomide refractory, with a safety profile consistent with what has been observed in the CARTITUDE clinical development program.
  • On June 22, 2021, Legend Biotech announced the establishment of a state-of-the-art manufacturing facility in Belgium as part of a joint investment with Janssen, to expand global manufacturing capacity of innovative cellular therapies.
  • On May 21, 2021, Legend Biotech completed the sale of 20,809,805 ordinary shares in a private placement at a purchase price of $14.41625 per ordinary share (equivalent to $28.8325 per American Depositary Share, or ADS) and the issuance of a warrant exercisable for up to an aggregate of 10,000,000 ordinary shares, exercisable for a two-year period at an exercise price of $20.00 per ordinary share (equivalent to $40.00 per ADS), in each case, pursuant to a subscription agreement dated May 13, 2021, with an institutional investor.
  • In June 2021, the CARTITUDE clinical program expanded to include the initiation of the CARTITUDE-5 study (NCT04923893), a Phase 3 randomized study evaluating cilta-cel in patients with newly diagnosed MM (NDMM) for whom autologous stem cell transplant (ASCT) is not planned as initial therapy. The CARTITUDE-5 study will evaluate bortezomib, lenalidomide and dexamethasone, known as VRd, followed by cilta-cel versus VRd, followed by lenalidomide and dexamethasone, or Rd, maintenance therapy.
  • The ongoing Phase 2 CARTITUDE-2 study (NCT04133636) was expanded with the addition of two cohorts: Cohort E (high-risk NDMM, transplant not planned) and Cohort F (standard-risk NDMM).
  • In May 2021, Legend Biotech achieved a $15 million milestone payment related to a cilta-cel development milestone, according to the terms and conditions of an agreement with Janssen.

*In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

Key Upcoming Milestones

  • As part of the acceptance of the BLA for cilta-cel for the treatment of adults with RRMM, the FDA has set the PDUFA target action date for November 29, 2021.
  • In collaboration with Janssen, Legend Biotech intends to present updated data from the CARTITUDE-1 and the CARTITUDE-2 studies at major medical conferences in 2021.
  • Legend Biotech anticipates supporting investigators to submit a manuscript on the clinical data update from LEGEND-2 study in 2021.
  • Legend Biotech intends to use the data from the CARTIFAN-1 study in support of a regulatory submission to the China Center for Drug Evaluation (CDE) in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM.
  • Legend Biotech’s collaboration partner, Janssen, anticipates submitting a New Drug Application (NDA) to the Japan Pharmaceuticals and Medical Devices Agency in the second half of 2021, seeking approval of cilta-cel for the treatment of adults with RRMM.
  • Legend Biotech expects to initiate its Phase 1 clinical trial of LB1901 in RR T-cell lymphoma (TCL) in the United States in 2021.

Financial Results for Three Months and Six Months Ended June 30, 2021

Cash and Cash Equivalents and Time Deposits

As of June 30, 2021, Legend Biotech had approximately $488.2 million of cash and cash equivalents and approximately $174.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2021 was $20.2 million compared to $11.6 million for the three months ended June 30, 2020. The increase of $8.6 million was primarily due to two additional milestones achieved pursuant to Legend Biotech’s agreement with Janssen in the fourth quarter of 2020 and in the second quarter of 2021, respectively. Revenue for the six months ended June 30, 2021 was $33.9 million compared to $23.1 million for the six months ended June 30, 2020. The increase of $10.8 million was primarily due to the aforementioned two additional milestones achieved. Milestone payments are constrained as a result of the uncertainty of whether the milestone will be achieved, but included as customer consideration for revenue recognition when the associated milestone is achieved and the uncertainty relieved. In half year of 2021, this resulted in a larger amount of revenue recognized from the contract liabilities. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2021 were $83.5 million compared to $53.6 million for the three months ended June 30, 2020. This increase of $29.9 million was primarily due to a higher number of clinical trials with more patients enrolled and a higher number of research and development product candidates. Consistently, research and development expenses for the six months ended June 30, 2021 was $154.5 million compared to $101.6 million for the six months ended June 30, 2020 with an $52.9 million increase.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2021 were $9.2 million compared to $4.5 million for the three months ended June 30, 2020. The increase of $4.7 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the six months ended June 30, 2021 increased by $10.1 million, which was $18.0 million for the six months ended June 30, 2021 compared to $7.9 million for the six months ended June 30, 2020.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2021 were $16.8 million compared to $9.6 million for the three months ended June 30, 2020. This increase of $7.2 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the six months ended June 30, 2021 was $30.2 million compared to $16.1 million for the six months ended June 30, 2020.

Other Income and Gains

Other income and gains for the three months ended June 30, 2021 was $1.7 million compared to $1.3 million for the three months ended June 30, 2020. Other income and gains for the six months ended June 30, 2021 was $2.4 million compared to $3.8 million for the six months ended June 30, 2020. The decrease of $1.4 million was primarily due to larger government grant and interest income received in the first half of the year in 2020.

Other Expenses

Other expenses for the three months ended June 30, 2021 was $2.3 million compared to $0.04 million for the three months ended June 30, 2020. The increase of $2.26 million was primarily due to higher foreign currency exchange loss, loss from disposal of assets and other expenses in the second quarter of 2021. Consistently, other expenses for the six months ended June 30, 2021 was $4.4 million compared to $0.08 million for the six months ended June 30, 2020, with an increase of $4.32 million.

Finance Costs

Finance costs for the six months ended June 30, 2021 was $0.09 million compared to $4.1 million for the six months ended June 30, 2020. The decrease was primarily due to finance costs related to the issuance of convertible redeemable preferred shares in 2020, which were fully converted into ordinary shares upon the completion of Legend Biotech’s initial public offering in June 2020.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the six months ended June 30, 2021 was $1.6 million caused by changes of fair value of a warrant, which was issued to an institutional investor through a private placement in May 2021. Concurrently, 20,809,805 ordinary shares were offered and sold to the institutional investor. The warrant was assessed as a financial liability with a fair value of $83.3 million as of June 30, 2021 and a fair value loss of $1.6 million was recorded for the six months ended June 30, 2021.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the six months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2021, net loss was $91.6 million, or $0.33 per share, compared to a net loss of $134.9 million, or $0.63 per share, for the three months ended June 30, 2020. Net loss was $172.5 million, or $0.63 per share, for the six months ended June 30, 2021 compared to $179.1 million, or $0.86 per share, for the six months ended June 30, 2020.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 900 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need. We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy that is being studied in a comprehensive clinical development program for the treatment of patients with multiple myeloma. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. Applications seeking approval of cilta-cel for the treatment of patients with relapsed/refractory multiple myeloma are currently under regulatory review by several health authorities around the world including the United States and Europe.

About the Cilta-cel Clinical Development Program

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma who have received at least three prior lines of therapy or are double refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI), received an IMiD, a PI and an anti-CD38 antibody, and documented disease progression within 12 months of starting the most recent therapy.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

CARTITUDE-2 (NCT04133636) is aglobal, multi-cohort Phase 2 study evaluating cilta-cel in patients with multiple myeloma in various clinical settings.2 This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive cilta-cel.

CARTITUDE-4 (NCT04181827) is a global, randomized Phase 3 study, evaluating cilta-cel in patients with multiple myeloma who have received 1-3 prior lines of therapy including a PI and IMiD and are refractory to lenalidomide.3 The study is being conducted to evaluate the efficacy of cilta-cel compared to standard therapies including daratumumab, pomalidomide and low-dose dexamethasone (DPd) or pomalidomide, bortezomib and low-dose dexamethasone (PVd).

CARTITUDE-5 (NCT04923893) is a global, randomized Phase 3 open-label study evaluating cilta-cel in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy.4 The study is being conducted to evaluate the efficacy of bortezomib, lenalidomide and dexamethasone (VRd) followed by cilta-cel vs. VRd followed by Rd maintenance.

CARTIFAN-1 (NCT03758417) is a Phase 2 confirmatory trial registered with the China Center for Drug Evaluation (CTR20181007) to further evaluate LCAR-B38M CAR-T cells in patients with advanced RRMM.5

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials, including the initiation of the phase 1 clinical trial of LB1901 in RR TCL; the ability to make, the timing of, and the ultimate success of, regulatory submissions globally, including the applications seeking approval of cilta-cel for the treatment of patients with RRMM submitted to health authorities around the world; the ability to generate, analyze and present data from clinical trials; patient enrollment; and the potential benefits of our product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 2, 2021. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this presentation as anticipated, believed, estimated or expected. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
   

Three months ended June 30

  

Six months ended June 30

(in thousands, US$, except share and per share data)

2021

  

2020

  

2021

  

2020

 

(Unaudited)

  

(Unaudited)

  

(Unaudited)

  

(Unaudited)
       
       

REVENUE

20,233

 

 

11,600

 

 

33,915

 

 

23,146

 

Other income and gains

1,668

 

 

1,265

 

 

2,390

 

 

3,796

 

Research and development expenses

(83,457

)

 

(53,567

)

 

(154,529

)

 

(101,570

)

Administrative expenses

(9,249

)

 

(4,508

)

 

(17,991

)

 

(7,938

)

Selling and distribution expenses

(16,782

)

 

(9,557

)

 

(30,199

)

 

(16,102

)

Other expenses

(2,344

)

 

(37

)

 

(4,378

)

 

(82

)

Fair value loss of warrant liability

(1,600

)

 

–

 

 

(1,600

)

 

–

 

Fair value loss of convertible redeemable preferred shares

–

 

 

(79,984

)

 

–

 

 

(79,984

)

Finance costs

(52

)

 

(88

)

 

(90

)

 

(4,079

)

       

LOSS BEFORE TAX

(91,583

)

 

(134,876

)

 

(172,482

)

 

(182,813

)

 

 

 

 

 

 

 

Income tax (expense)/credit

(1

)

 

–

 

 

(1

)

 

3,709

 

 

 

 

 

 

 

 

LOSS FOR THE PERIOD

(91,584

)

 

(134,876

)

 

(172,483

)

 

(179,104

)

Attributable to:

 

 

 

 

 

 

 

Equity holders of the parent

(91,584

)

 

(134,876

)

 

(172,483

)

 

(179,104

)

 

 

 

 

 

 

 

Loss per share attributable to ordinary equity holders of the parent:

 

 

 

 

 

 

 

Ordinary shares – basic

(0.33

)

 

(0.63

)

 

(0.63

)

 

(0.86

)

Ordinary shares – diluted

(0.33

)

 

(0.63

)

 

(0.63

)

 

(0.86

)

 

 

 

 

 

 

 

Shares used in loss per share computation:

 

 

 

 

 

 

 

Ordinary shares – basic

277,016,799

 

 

215,551,887

 

 

271,684,977

 

 

207,775,944

 

Ordinary shares – diluted

277,016,799

 

 

215,551,887

 

 

271,684,977

 

 

207,775,944

 

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
   

June 30, 2021

(Unaudited)

  

December 31, 2020

(in thousands, US$)

  

 

 

 

 

NON-CURRENT ASSETS

  

Property, plant and equipment

135,216

 

113,091

Advance payments for property, plant and equipment

2,197

 

224

Right-of-use assets

7,312

 

8,009

Other non-current assets

4,885

 

3,973

Intangible assets

4,681

 

2,852

 

 

 

 

Total non-current assets

154,291

  

128,149

 

 

 

 

CURRENT ASSETS

 

 

Inventories

1,700

 

1,800

Trade receivables

15,000

 

74,978

Prepayments, other receivables and other assets

11,170

 

10,007

Financial investment measured at amortized cost

29,849

 

–

Pledged short-term deposits

256

 

384

Time deposits

174,644

 

50,000

Cash and cash equivalents

488,215

 

455,689

 

 

 

 

Total current assets

720,834

  

592,858

 

 

 

 

Total assets

875,125

  

721,007

 

 

 

 

CURRENT LIABILITIES

 

 

Trade and notes payables

11,001

 

5,238

Other payables and accruals

109,183

 

99,168

Government grants

300

 

283

Warrant Liability

83,300

 

–

Lease liabilities

1,178

 

1,464

Contract liabilities

56,139

 

55,014

 

 

 

 

Total current liabilities

261,101

  

161,167

 

 

 

 

NON-CURRENT LIABILITIES

 

 

Contract liabilities

252,628

 

275,071

Lease liabilities

1,621

 

1,909

Interest-bearing loans and borrowings

17,310

 

–

Other non-current liabilities

554

 

554

Government grants

1,992

 

2,051

 

 

 

 

Total non-current liabilities

274,105

  

279,585

 

 

 

 

Total liabilities

535,206

  

440,752

 

 

 

 

EQUITY

 

 

Share capital

29

 

27

Reserves

339,890

 

280,228

 

 

 

 

Total ordinary shareholders’ equity

339,919

  

280,255

 

 

 

 

Total equity

339,919

  

280,255

 

 

 

 

Total liabilities and equity

875,125

  

721,007

LEGEND BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
   

 

Three months ended June 30

  

Six months ended June 30

(in thousands, US$)

2021

  

2020

  

2021

  

2020

 

(Unaudited)

  

(Unaudited)

  

(Unaudited)

  

(Unaudited)

 

 

 

 

 

 

 

 

LOSS BEFORE TAX

(91,583

)

 

(134,876

)

 

(172,482

)

 

(182,813

)

 

 

 

 

 

 

 

 

CASH FLOWS USED IN OPERATING ACTIVITIES

(57,538

)

 

(56,885

)

 

(84,325

)

 

(102,681

)

 

 

 

 

 

 

 

 

CASH FLOWS USED IN INVESTING ACTIVITIES

(168,673

)

 

(9,212

)

 

(185,823

)

 

(26,711

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

301,752

 

 

459,803

 

 

301,959

 

 

608,558

 

 

 

 

 

 

 

 

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

75,541

 

 

393,706

 

 

31,811

 

 

479,166

 

 

 

 

 

 

 

 

 

Effect of foreign exchange rate changes, net

378

 

 

(112

)

 

715

 

 

(139

)

Cash and cash equivalents at beginning of the period

412,296

 

 

168,797

 

 

455,689

 

 

83,364

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS AT END OF THE PERIOD

488,215

 

 

562,391

 

 

488,215

 

 

562,391

 

 

 

 

 

 

 

 

 

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS

 

 

 

 

 

 

 

Cash and bank balances

663,115

 

 

638,206

 

 

663,115

 

 

638,206

 

Less: Pledged short-term deposits

256

 

 

256

 

 

256

 

 

256

 

Time deposits

174,644

 

 

75,559

 

 

174,644

 

 

75,559

 

Cash and cash equivalents as stated in the statement of financial position

488,215

 

 

562,391

 

 

488,215

 

 

562,391

 

Cash and cash equivalents as stated in the statement of cash flows

488,215

 

 

562,391

 

 

488,215

 

 

562,391

 

________________________________

1 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Last accessed Aug 2021.

2 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04133636. Last accessed Aug 2021.

3 ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Available at: https://clinicaltrials.gov/ct2/show/NCT04181827. Last accessed Aug 2021.

4 ClinicalTrials.gov. A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5) Available at: https://clinicaltrials.gov/ct2/show/NCT04923893. Last accessed Aug 2021.

5 ClinicalTrials.gov. A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma (CARTIFAN-1). https://clinicaltrials.gov/ct2/show/NCT03758417. Last accessed Aug 2021.

Investor Contacts:

Jessie Yeung, Head of Corporate Finance and Investor Relations, Legend Biotech [email protected] or [email protected]

Crystal Chen, Manager of Investor Relations and Corporate Communications, Legend Biotech

[email protected]

Press Contact:

Tina Carter, Corporate Communications Lead, Legend Biotech

[email protected] or [email protected]

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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SES, a Lithium-Metal Battery Supplier for Electric Vehicles, to Participate in the Raymond James 2021 Diversified Industrials Conference

SES, a Lithium-Metal Battery Supplier for Electric Vehicles, to Participate in the Raymond James 2021 Diversified Industrials Conference

BOSTON–(BUSINESS WIRE)–
SES Holdings Pte. Ltd. (“SES”), the world leader in the development and manufacturing of high-performance hybrid Lithium-Metal (Li-Metal) rechargeable batteries for electric vehicles (“EVs”), announced today that Rohit Makharia, President and COO of SES, will participate in a virtual panel called Zero-Emission Transport: Comparative Perspectives on Hydrogen and Electric Mobilityat the Raymond James 2021 Diversified Industrials Conference on Wednesday, August 25.

SES has previously announced that it entered into a business combination agreement with Ivanhoe Capital Acquisition Corp. (NYSE: IVAN) (“Ivanhoe”), a special purpose acquisition company (SPAC), pursuant to which SES will become a wholly-owned subsidiary of Ivanhoe.

About SES

SES is the world leader in development and manufacturing of high-performance Li-Metal batteries for automotive and transportation applications. Founded in 2012, SES is an integrated Li-Metal battery manufacturer with strong capabilities in material, cell, module, AI-powered safety algorithms, and recycling. Formerly known as SolidEnergy Systems, SES is headquartered in Singapore and has operations in Boston, Shanghai and Seoul.

About Ivanhoe Capital Acquisition Corp.

Ivanhoe Capital Acquisition Corp. (NYSE: IVAN) is a special purpose acquisition company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. Ivanhoe was formed to seek a target in industries related to the paradigm shift away from fossil fuels towards the electrification of industry and society.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are “forward-looking statements.” Forward-looking statements can generally be identified by the use of words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “forecast,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” “target” and other similar expressions that predict or indicate future events or events or trends that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of other financial and performance metrics, projections of market opportunity and market share. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of SES’s and Ivanhoe’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions, and such differences may be material. Many actual events and circumstances are beyond the control of SES and Ivanhoe. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; the inability of the parties to successfully or timely consummate the business combination, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the business combination or that the approval of the shareholders of SES or Ivanhoe is not obtained; the failure to realize the anticipated benefits of the business combination; risks relating to the uncertainty of the projected financial information with respect to SES; risks related to the development and commercialization of SES’s battery technology and the timing and achievement of expected business milestones; the effects of competition on SES’s business; the risk that the business combination disrupts current plans and operations of Ivanhoe and SES as a result of the announcement and consummation of the business combination; the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and retain its management and key employees; risks relating SES’s history of no revenues and net losses; the risk that SES’s joint development agreements and other strategic alliances could be unsuccessful; risks relating to delays in the design, manufacture, regulatory approval and launch of SES’s battery cells; the risk that SES may not establish supply relationships for necessary components or pay components that are more expensive than anticipated; risks relating to competition and rapid change in the electric vehicle battery market; safety risks posed by certain components of SES’s batteries; risks relating to machinery used in the production of SES’s batteries; risks relating to the willingness of commercial vehicle and specialty vehicle operators and consumers to adopt electric vehicles; risks relating to SES’s intellectual property portfolio; the amount of redemption requests made by Ivanhoe’s public shareholders; the ability of Ivanhoe or the combined company to issue equity or equity-linked securities or obtain debt financing in connection with the business combination or in the future and those factors discussed in Ivanhoe’s Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 31, 2021, under the heading “Risk Factors,” and other documents of Ivanhoe filed, or to be filed, with the SEC relating to the business combination. If any of these risks materialize or Ivanhoe’s or SES’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither Ivanhoe nor SES presently know or that Ivanhoe and SES currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Ivanhoe’s and SES’s expectations, plans or forecasts of future events and views only as of the date of this press release. Ivanhoe and SES anticipate that subsequent events and developments will cause Ivanhoe’s and SES’s assessments to change. However, while Ivanhoe and SES may elect to update these forward-looking statements at some point in the future, Ivanhoe and SES specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Ivanhoe’s and SES’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Additional Information

This press release relates to the proposed business combination between Ivanhoe and SES. This press release does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Ivanhoe has filed a Registration Statement on Form S-4 with the SEC, which includes a document that serves as a joint prospectus and proxy statement, referred to as a proxy statement/prospectus, and which has not yet become effective. A proxy statement/prospectus will be sent to all Ivanhoe shareholders. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom. Ivanhoe will also file other documents regarding the proposed business combination with the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF IVANHOE ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ALL OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED BUSINESS COMBINATION AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION.

Investors and security holders will be able to obtain free copies of the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Ivanhoe through the website maintained by the SEC at www.sec.gov. The documents filed by Ivanhoe with the SEC also may be obtained free of charge upon written request to Ivanhoe Capital Acquisition Corp., 1177 Avenue of the Americas, 5th Floor, New York, New York 10036.

Participants in the Solicitation

Ivanhoe, SES and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Ivanhoe’s shareholders in connection with the proposed business combination. You can find information about Ivanhoe’s directors and executive officers and their interest in Ivanhoe can be found in Ivanhoe’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the SEC on March 31, 2021. A list of the names of the directors, executive officers, other members of management and employees of Ivanhoe and SES, as well as information regarding their interests in the business combination, are contained in the Registration Statement on Form S-4 filed with the SEC by Ivanhoe. Additional information regarding the interests of such potential participants in the solicitation process may also be included in other relevant documents when they are filed with the SEC. You may obtain free copies of these documents from the sources indicated above.

For investor inquiries, please contact: [email protected]

For media inquiries, please contact: [email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Alternative Vehicles/Fuels Automotive Manufacturing Manufacturing Environment Automotive

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Zix Sets September Financial Conference Schedule

Zix Sets September Financial Conference Schedule

DALLAS–(BUSINESS WIRE)–Zix Corporation (Zix) (NASDAQ: ZIXI), a leading provider of cloud email security, productivity, and compliance solutions, is scheduled to participate at the following virtual financial conferences during September:

10th Annual Gateway Conference

Wednesday, September 8, 2021 at 1:00 p.m. ET with one-on-one meetings throughout the day

Webcast

Colliers 2021 Institutional Investor Conference

Thursday, September 9, 2021

One-on-one meetings only

Jefferies Virtual Software Conference

Wednesday, September 15, 2021 at 9:00 a.m. ET with one-on-one meetings throughout the day

Webcast

To receive additional information or to schedule a one-on-one meeting, please contact Zix’s IR team at [email protected].

About Zix Corporation

Zix Corporation (Zix) is a leader in email security. Trusted by the nation’s most influential institutions in healthcare, finance, and government, Zix delivers a superior experience and easy-to-use solutions for email encryption and data loss prevention, advanced threat protection, unified information archiving and bring your own device (BYOD) mobile security. Focusing on the protection of business communication, Zix enables its customers to better secure data and meet compliance needs. Zix is publicly traded on the Nasdaq Global Market under the symbol ZIXI. For more information, visit www.zixcorp.com.

Zix Company Contact

Geoff Bibby

1-214-370-2241

[email protected]

Zix Investor Contact

Matt Glover and Tom Colton

Gateway Investor Relations

1-949-574-3860

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Security Technology Other Technology Telecommunications Mobile/Wireless Networks Internet

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RSI to Participate at the Craig-Hallum Online Gaming Conference

RSI to Participate at the Craig-Hallum Online Gaming Conference

CHICAGO–(BUSINESS WIRE)–
Rush Street Interactive, Inc. (NYSE: RSI) (“RSI” or the “Company”), a leading online casino and sports betting company in the United States, today announced that Richard Schwartz, Co-Founder and Chief Executive Officer will participate in a fireside chat at Craig-Hallum’s Online Gaming Conference on Tuesday, August 24, 2021 at 3:30 p.m. Eastern Time. The topic to be discussed will be on “Emerging Opportunities in Latin America.”

Access to a live audio-webcast of the presentation in listen-only mode will be available through the “Investors” section of the Company’s website at www.rushstreetinteractive.com. A replay of the webcast will be archived on the Company’s website for 90 days.

About RSI

RSI is a trusted online gaming and sports entertainment company focused on regulated markets in the United States and Latin America. Through its brands, BetRivers.com and PlaySugarHouse.com, RSI was an early entrant in many regulated jurisdictions and is currently live with real-money mobile, online and/or retail operations in ten U.S. states: Pennsylvania, Illinois, New Jersey, New York, Michigan, Indiana, Virginia, Colorado, Iowa and West Virginia. RSI is also active internationally, offering its online casino and sportsbook in the regulated gaming market of Colombia on RushBet.co. RSI offers, through its proprietary online gaming platform, some of the most popular online casino games and sports betting options in the United States. Founded in 2012 in Chicago by gaming industry veterans, RSI was named the 2020 Global Gaming Awards Digital Operator of the Year and the 2021 EGR North America Awards Casino Operator of the Year, Customer Services Operator of the Year and Social Gaming Operator of the Year. RSI is committed to industry-leading responsible gaming practices and seeks to provide its customers with the resources and services they need to play responsibly. For more information, visit www.rushstreetinteractive.com.

For RSI Contacts:

Media:

Lisa Johnson

(609) 788-8548

[email protected]

or

Jonathan Gasthalter/Carissa Felger/Sam Fisher

(312) 319-9233 / (212) 257-4170

[email protected]

Investors:

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Casino/Gaming Entertainment

MEDIA:

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UiPath Announces Major Partner Sponsors Supporting FORWARD IV, the Largest Global Conference for Automation Professionals

UiPath Announces Major Partner Sponsors Supporting FORWARD IV, the Largest Global Conference for Automation Professionals

Two-day event will feature unique COVID precautions for a safe, immersed, and engaging experience and keynote addresses by UiPath leaders on the future of automation

NEW YORK–(BUSINESS WIRE)–
UiPath, Inc. (NYSE: PATH), a leading enterprise automation software company, today announced sponsorships are nearly sold out for its user conference, FORWARD IV, taking place at the Bellagio in Las Vegas on Oct. 5-6, 2021. The conference represents the largest global gathering of automation experts and practitioners, with thousands expected to attend to hear UiPath experts, customers, partners, and notable guest speakers showcasing how automation is accelerating human achievement.

For the health, safety, and well-being of all participants, UiPath is requiring all FORWARD IV attendees to attest to their having been fully vaccinated against COVID-19. Read more about our health and safety measures and our first-of-its-kind “inside-out” event experience.

The FORWARD IV theme, “Taking Off,” is a celebration of organizations that are making digital transformation a reality. The past year has shaped new thinking for businesses after facing a high velocity of change – the conference is a forum to share innovative ideas, to collaborate and forge new connections, and to unleash creativity in an automation-first world. The event will highlight the achievements of the UiPath community and provide attendees actionable insights to advance their journey to becoming a fully automated enterprise™.

To date, customers and partners sponsoring FORWARD IV include:

  • Strategic Technology sponsors:AWS and Microsoft
  • Diamond sponsors: Accenture; CGI; Cognizant; Deloitte; PwC
  • Ruby sponsors: Abbyy; Accelirate; Ashling Partners; Amitech; Huron Consulting Group; Indico; Infosys; Lanshore; Roboyo; and RPA Supervisor
  • Emerald sponsors: Alteryx; BeeckerCo; Centelli; CIGNEX; CyberArk; Firestart; Firstsource; Genpact; Greenlight Consulting; EPAM Systems; Globant; HCL; JOLT Advantage Group; Kodak Alaris; Lydonia Technologies; Machina; Miracle Software; Modex; Neostella; Reveal Group; Sauce Labs; Sykes; TSP; and Tquila Automation

Keynote speeches will be delivered by UiPath CEO Daniel Dines on the future of automation and defining trends in its evolution, and UiPath Executive Vice President of Products and Engineering Ted Kummert, who will outline the vision for the UiPath platform. UiPath Chief Product Officer Param Kahlon will demonstrate how that vision is being brought to life with new platform innovations.

FORWARD IV balances inspiring keynotes with hands-on product training. Sessions will focus on topics such as governance, security, scaling, upskilling, and employee and customer satisfaction as well as the latest on the UiPath Platform. The event builds in unstructured time to allow attendees to get immersed in conversations with other automation practitioners and experts. In addition, the conference will prioritize safety and will limit capacity within different functional areas of the venue, enforce practical distancing and sanitizing measures, and adhere to national and local guidelines.

“Our customers and partners are our biggest source of inspiration at UiPath. With this ecosystem, we strive to expand the art of the possible, with automation helping to solve some of the biggest challenges businesses face today,” said Thomas Hansen, Chief Revenue Officer at UiPath. “Demand for automation technology is burgeoning, and at FORWARD, attendees will have a first look at the flourishing ideas and new automation-first concepts from UiPath that they can apply within their own organizations. We are excited to have so many partners and customers joining us as sponsors to offer a one-of-a-kind experience.”

To register to attend and learn more about UiPath FORWARD IV, please visit here.

About UiPath

UiPath has a vision to deliver the Fully Automated Enterprise™, one where companies use automation to unlock their greatest potential. UiPath offers an end-to-end platform for automation, combining the leading Robotic Process Automation (RPA) solution with a full suite of capabilities that enable every organization to rapidly scale digital business operations.

Media

Pete Daly

UiPath

[email protected]

Investor Relations

Kelsey Turcotte

UiPath

[email protected]

KEYWORDS: United States North America Nevada New York

INDUSTRY KEYWORDS: Software Technology Internet Data Management

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Installed Building Products Announces Upcoming Investor Conference Schedule

Installed Building Products Announces Upcoming Investor Conference Schedule

COLUMBUS, Ohio–(BUSINESS WIRE)–
Installed Building Products, Inc. (the “Company” or “IBP”) (NYSE: IBP), an industry-leading installer of insulation and complementary building products, today announced that members of management will participate virtually in the following investor conferences:

On September 9, 2021, Michael Miller, Chief Financial Officer, and Jeffrey Hire, President of External Affairs, are scheduled to attend the RBC Capital Markets Conference.

On September 21, 2021, Jeff Edwards, Chairman and Chief Executive Officer, Michael Miller, Chief Financial Officer, and Jeffrey Hire, President of External Affairs, are scheduled to attend the Zelman & Associates Virtual Housing Summit.

About Installed Building Products

Installed Building Products, Inc. is one of the nation’s largest new residential insulation installers and is a diversified installer of complementary building products, including waterproofing, fire-stopping, fireproofing, garage doors, rain gutters, window blinds, shower doors, closet shelving and mirrors and other products for residential and commercial builders located in the continental United States. The Company manages all aspects of the installation process for its customers, from direct purchase and receipt of materials from national manufacturers to its timely supply of materials to job sites and quality installation. The Company offers its portfolio of services for new and existing single-family and multi-family residential and commercial building projects from its national network of over 190 branch locations.

Investor Relations:

614-221-9944

[email protected]

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Residential Building & Real Estate Commercial Building & Real Estate Construction & Property Building Systems

MEDIA:

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Amneal Announces Virtual Event to Discuss Initial Data from Pivotal Phase 3 Study of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations

Amneal Announces Virtual Event to Discuss Initial Data from Pivotal Phase 3 Study of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations

BRIDGEWATER, N.J.–(BUSINESS WIRE)–
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that it will host a virtual event for the investment community on Wednesday, August 25, 2021 at 4:30 p.m. ET. The upcoming event will feature members of Amneal’s management team as well as Alberto Espay, MD, MSc, FAAN, FANA (University of Cincinnati), and Robert A Hauser, MD, MBA, FAAN (University of South Florida). The presentation will be followed by a live Q&A session.

Please visit https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MTM2Mg== to register and access the live webinar. A replay will be made available on the company’s website for six months following the conclusion of the event.

About IPX-203

IPX-203 is a investigational product not approved by the FDA. IPX-203 is a novel, oral formulation of extended-release CD/LD for patients experiencing motor fluctuations. IPX-203 was developed with an innovative formulation that contains immediate-release and extended-release granules and uses mucoadhesive polymers to provide rapid absorption and maximize levodopa absorption. This formulation is distinct from RYTARY (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of approximately 250 generic product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

Investor Contact

Anthony DiMeo

Senior Director, Investor Relations

[email protected]

Media Contact

Julie Normart

Group Director, Media and Engagement, Real Chemistry

[email protected]

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

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Merida Merger Corp. I Plans to Delist From the NEO Exchange

Merida Merger Corp. I Plans to Delist From the NEO Exchange

NEW YORK–(BUSINESS WIRE)–
As previously announced, Merida Merger Corp. I (NEO: MMK.U) (“Merida”) entered into a definitive agreement for a business combination with Leafly Holdings, Inc. (“Leafly”). As part of the transaction, Merida expects to voluntarily delist from the NEO Exchange (“NEO”) at the close of trading on or about Wednesday, September 1, 2021. Merida will continue to be listed and trade on Nasdaq (NASDAQ: MCMJ).

“We appreciate the working relationship we have with NEO and are grateful for the flexibility and professionalism of our partners there,” said Peter Lee, President of Merida. “Our shares will continue to be listed on Nasdaq alongside several of our peers in the ancillary cannabis sector.”

About Merida Merger Corp. I

Merida is a blank check company formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities.

About the NEO Exchange

The NEO Exchange is a Canadian Tier 1 stock exchange for the innovation economy, bringing together investors and capital raisers within a fair, liquid, efficient, and service-oriented environment. Fully operational since June 2015, NEO puts investors first and provides access to trading across all Canadian-listed securities on a level playing field. NEO lists companies and investment products seeking an internationally recognized stock exchange that enables investor trust, quality liquidity, and broad awareness including unfettered access to market data.

Additional Information and Where to Find It

In connection with the proposed business combination contemplated by the Agreement and Plan of Merger by and among Merida, Merida Merger Sub, Inc., Merida Merger Sub II, LLC, and Leafly (the “Merger Agreement”), Merida intends to file a registration statement on Form S-4 (the “Registration Statement”) that will include a proxy statement of Merida, a prospectus of Merida and a consent solicitation statement of Leafly. The proxy statement/prospectus/consent solicitation statement will be sent to all Merida and Leafly stockholders as of a record date to be established for voting on the proposed business combination and the other matters to be voted upon at a meeting of Merida’s stockholders to be held to approve the proposed business combination and other matters (the “Special Meeting”). Merida may also file other documents regarding the proposed business combination with the SEC. The definitive proxy statement/prospectus/consent solicitation statement will contain important information about the proposed business combination and the other matters to be voted upon at the Special Meeting and is not intended to provide the basis for any investment decision or any other decision in respect of such matters. Before making any voting decision, investors and security holders of the Merida and Leafly are urged to read the Registration Statement, the proxy statement/prospectus/consent solicitation statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed business combination as they become available because they will contain important information about the proposed business combination and related matters.

Investors and security holders will be able to obtain free copies of the proxy statement/prospectus/consent solicitation statement and all other relevant documents filed or that will be filed with the SEC by Merida through the website maintained by the SEC at www.sec.gov.

Participants in Solicitation

Merida and Leafly and their respective directors and officers may be deemed to be participants in the solicitation of proxies from Merida’s stockholders in connection with the proposed business combination. Information about Merida’s directors and executive officers and their ownership of Merida’s securities is set forth in Merida’s filings with the SEC. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed business combination may be obtained by reading the proxy statement/prospectus/consent solicitation statement regarding the proposed business combination when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

Forward-Looking Statements

This document contains certain forward-looking statements within the meaning of the federal securities laws with respect to the proposed business combination between Merida and Leafly, including statements regarding the benefits of the proposed business combination, the anticipated timing of the proposed business combination, the services offered by Leafly and the markets in which Leafly operates, business strategies, debt levels, industry environment, potential growth opportunities, the effects of regulations and Merida’s or Leafly’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “forecast,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions (including the negative versions of such words or expressions).

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the proposed business combination may not be completed in a timely manner or at all, which may adversely affect the price of Merida’s securities; (ii) the risk that the proposed business combination may not be completed by Merida’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Merida; (iii) the failure to satisfy the conditions to the consummation of the proposed business combination, including the approval of the proposed business combination by Merida’s stockholders, the satisfaction of the minimum trust account amount following redemptions by Merida’s public stockholders and the receipt of certain governmental and regulatory approvals; (iv) the effect of the announcement or pendency of the proposed business combination on Merida’s or Leafly’s business relationships, performance, and business generally; (v) risks that the proposed business combination disrupts current plans of Leafly and potential difficulties in Leafly employee retention as a result of the proposed business combination; (vi) the outcome of any legal proceedings that may be instituted against Merida or Leafly related to the Merger Agreement or the proposed business combination; (vii) the ability to maintain the listing of Merida’s securities on the NASDAQ; (viii) the price of Merida’s securities, including volatility resulting from changes in the competitive and highly regulated industry in which Leafly plans to operate, variations in performance across competitors, changes in laws and regulations affecting Leafly’s business and changes in the combined capital structure; and (ix) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed business combination, and identify and realize additional opportunities. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that will be described in the Company’s final proxy statement/prospectus/consent solicitation statement contained in the Registration Statement, including those under “Risk Factors” therein, and other documents filed by Merida from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Merida and Leafly assume no obligation and, except as required by law, do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither Merida nor Leafly gives any assurance that either Merida or Leafly will achieve its expectations.

Disclaimer

This document relates to a proposed business combination between Merida and Leafly. This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Media

Laura Morarity

[email protected]

206-489-8427

Investors

Peter Lee

President and CFO

[email protected]

KEYWORDS: United States North America Canada Washington New York

INDUSTRY KEYWORDS: Alternative Medicine Professional Services Retail Health Tobacco Specialty Finance

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